# K183016: SteriCap Mini Needle

- Pathway: 510(k) (Special)
- Applicant: Ocujet, LLC
- Decided: May 7, 2019 after 188 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970370 (1997). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170768: Mini Needle, Ocuject, LLC (2017) Summary page 4.

## Most influential descendants
- K212805: SteriCap Mini Needle and Standard Needles (2021), 3 descendants of its own
- K230959: VitreJect® Needle; OcuSafe® Needle (2023), 2 descendants of its own
- K233343: SteriCap Safety Needle; VitreJect Safety Needle (2023), 1 descendant of its own
- K242956: LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (2024), 0 descendants of its own

## Indications for use
The SteriCap™ Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs.

Source page: https://510kreport.com/device/K183016
Methodology: https://510kreport.com/methodology